Every regulation starts with scope, and it’s tempting to skim past it. You know what you make. You know you’re FDA-regulated. Why spend time on §820.1?
Here’s why: scope defines the boundaries of your obligations. Read it carefully once — really carefully — and you may find that some of what you’ve been doing is more than the regulation requires, or that a corner of your operation you’d never thought about is actually covered. I’ve seen both happen, sometimes in the same company on the same day.
So let’s take §820.1 seriously.
The Basic Scope: What Hasn’t Changed
The QMSR applies to manufacturers of finished medical devices intended for commercial distribution in the United States. That part you already knew. If you design, manufacture, package, label, install, or service finished devices sold in the U.S. market, you’re covered. That hasn’t changed from the old QSR.
What has changed is the framework within which those requirements sit. Because the QMSR incorporates ISO 13485:2016 by reference, the scope of the underlying standard now matters too. ISO 13485’s scope is somewhat broader in some respects — it explicitly includes organizations involved in any stage of the life cycle of a medical device, including those providing post-market services. The QMSR inherits this framing.
The Surprises Worth Knowing About
Contract manufacturers are firmly in scope. This was true under the old QSR too, but the QMSR’s incorporation of ISO 13485 makes the supply chain implications more explicit. If you manufacture finished devices under contract — even if your name never appears on the label — you are subject to the QMSR. Full stop. I mention this because I still encounter contract manufacturers who believe they’re operating under their customer’s quality system rather than their own. That’s not how it works.
Component manufacturers generally remain out of scope — but read the footnotes. Manufacturers of components or parts that will be further processed into finished devices are not directly subject to Part 820. However, if you are also the specification developer for the finished device, or if FDA determines that your component is itself a finished device, that exemption disappears. When in doubt, the analysis depends on your specific situation, and it’s worth getting right.
Software developers, pay attention. Software as a Medical Device (SaMD) has been a growing area of FDA focus, and the QMSR’s alignment with ISO 13485 brings with it clearer expectations for software lifecycle processes. If your organization develops software that meets the definition of a medical device — and the definition is broader than many people assume — you are in scope. This is one area where I’d encourage anyone with a software product to review FDA’s current SaMD guidance alongside the QMSR.
The “small manufacturer” question. The QMSR, like the old QSR, does not provide a general small-business exemption. Size does not determine applicability. What it may affect is how FDA prioritizes inspection resources — but your obligations under the regulation are the same regardless of whether you have 10 employees or 10,000.
What §820.1 Means Practically
For most established manufacturers, your scope analysis probably doesn’t change much under the QMSR. But I’d suggest treating this as a good moment to do a quick review of three things:
First, confirm that your Quality Manual (which we’ll cover in detail when we reach §820.15) accurately describes the scope of your QMS — what sites, what product lines, and what activities are included. Auditors look at this, and inconsistencies between your stated scope and your actual operations are a reliable source of observations.
Second, if you work with contract manufacturers or critical suppliers, verify that they understand their own obligations under the QMSR. Your purchasing controls (§820.50) need to account for this, and we’ll go deep on that when we get there.
Third, if your organization develops or incorporates software, now is a good time to confirm whether any of that software meets the definition of a medical device and whether your QMS adequately covers its lifecycle.
A Note on Exemptions
The QMSR does carry forward certain exemptions from the old QSR — most notably for custom devices and certain research-use-only products. These are narrow and specific. If you’ve historically relied on an exemption, verify that it still applies under the QMSR’s language and that nothing in your operation has changed to affect your eligibility.
You’re in Good Shape
I want to close every one of these posts the same way I’d close a conversation with a client: with honesty about what’s hard, and genuine encouragement about what’s manageable. The scope section of the QMSR is not where compliance gets complicated. It’s where you confirm you’re at the right table — and for most of you reading this, you already knew you were.
Next up: §820.3 — Definitions. The QMSR brought some meaningful terminology changes, and a few of them have real practical implications. I’ll flag the ones that matter most.
See you then.
This series is a plain-English walkthrough of the QMSR — written for the people who actually have to implement it.